Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with MASH and fibrosis (scarring).

勃林格宣布开始两项舒沃杜肽的III期临床试验，用于治疗患有MASH和纤维化（瘢痕形成）的成年人。

LIVERAGE will examine whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment and reduce the risk of end-stage liver disease outcomes after approximately seven years of treatment in adults living with MASH and moderate or advanced liver fibrosis (stages 2 or 3). LIVERAGE-Cirrhosis will examine whether survodutide can reduce the risk of end-stage liver disease outcomes after approximately four and a half years of treatment in adults living with MASH and compensated cirrhosis (fibrosis stage 4), a condition where the liver presents severe scarring..

LIVERAGE将检查survodutide是否可以在治疗52周后改善MASH和/或纤维化，并在患有MASH和中度或晚期肝纤维化的成年人中治疗约7年后降低终末期肝病结局的风险（阶段2或3）。肝硬化将检查在患有MASH和代偿性肝硬化（纤维化阶段4）的成年人中，经过大约四年半的治疗后，舒沃杜肽是否可以降低终末期肝病结局的风险，这种情况下肝脏会出现严重的疤痕。。

“Given the significant burden of MASH and the limited therapeutic options, novel approaches are urgently needed,” said Dr. Arun Sanyal, M.D., Professor of Medicine at Virginia Commonwealth University School of Medicine and Director of VCU’s Stravitz-Sanyal Institute for Liver Disease and Metabolic Health.

弗吉尼亚联邦大学医学院医学教授、VCU斯特拉维茨·桑亚尔肝病与代谢健康研究所所长阿伦·桑亚尔博士说：“鉴于MASH的巨大负担和有限的治疗选择，迫切需要新的方法。”。

“The Phase III LIVERAGE studies represent an exciting opportunity to investigate whether survodutide, with its dual glucagon and GLP-1 receptor agonist mechanism of action, can help address this significant medical need.”.

“III期肝病研究提供了一个令人兴奋的机会，可以研究具有双重胰高血糖素和GLP-1受体激动剂作用机制的苏伏都肽是否有助于解决这一重大的医疗需求。”。

About LIVERAGE and LIVERAGE-Cirrhosis

关于肝病和肝硬化

LIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (stage 4), respectively. LIVERAGE will enroll approximately 1,800 adults, and LIVERAGE-Cirrhosis will enroll approximately 1,590 adults.

LIVERAGE和LIVERAGE肝硬化是全球III期临床试验，分别研究了survodutide在成人MASH和纤维化2期或3期以及代偿性MASH肝硬化（4期）患者中的疗效和安全性。肝病将招收约1800名成年人，肝硬化将招收约1590名成年人。

In each trial, participants will be randomized to receive weekly injections of either survodutide, reaching a maximum dose of 6 mg, or placebo. .

在每项试验中，参与者将被随机分配接受每周注射最大剂量为6毫克的舒沃杜肽或安慰剂。。

LIVERAGE consists of two parts. The two primary endpoints of part one are proportion of patients achieving MASH resolution without worsening of fibrosis, and at least a 1-point improvement in fibrosis without worsening of MASH, after 52 weeks of treatment. The primary endpoint of part two, which will continue for approximately seven years, is time to first occurrence of liver-related events or all-cause mortality. .

肝脏由两部分组成。。第二部分的主要终点将持续大约七年，是首次发生肝脏相关事件或全因死亡率的时间。。

The primary endpoint of LIVERAGE-Cirrhosis, which will continue for approximately four and a half years, is the time to first occurrence of all-cause mortality or liver-related events.

肝硬化的主要终点将持续大约四年半，是首次发生全因死亡率或肝脏相关事件的时间。

Condition: Metabolic Dysfunction-Associated Steatohepatitis

条件：代谢功能障碍相关的脂肪性肝炎

Type: drug

类型：药物